Trial · NCT07466316
A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)
NCT07466316, Phase 3, Recruiting, Children's Oncology Group
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS). Trials, record NCT07466316. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07466316
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)
- NCT number
- NCT07466316
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 342 participants, estimated
- Lead sponsor
- Children's Oncology Group
- Conditions
- Rhabdomyosarcoma
- Interventions
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Computed Tomography, Cyclophosphamide, Dactinomycin, Irinotecan Hydrochloride, Lumbar Puncture, Lymph Node Biopsy, Magnetic Resonance Imaging, Positron Emission Tomography, Radiation Therapy, Resection, Survey Administration, Vincristine Sulfate, Vinorelbine Tartrate
- First posted
- 2026-03-12
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event free survival (EFS) | From randomization until the first occurrence of progression or relapse, second malignancy, or death, assessed up to 5 years | Will be estimated using the Kaplan-Meier method and will be compared between the randomized treatment groups using the stratified log-rank test. |
| Secondary | Overall survival (OS) | From randomization to death from any cause, assessed up to 4 years | Will be estimated using the Kaplan-Meier method and will be compared between the randomized treatment groups using the stratified log-rank test. |
| Secondary | Clinician-reported adverse events (AEs) | Up to 5 years | Clinician-reported treatment-related grade 3 or higher AEs will be reported using Common Terminology Criteria for Adverse Events version 5.0. Comparison of toxicities will be conducted using Fisher's exact test. The maximum grade for each toxicity will be recorded for each patient. Averages and confidence intervals for these toxicity frequencies will be provided. |
| Secondary | Proportion of patients undergoing delayed primary excision (DPE) among patients deemed to be DPE eligible on retrospective central review | Up to week 12 of treatment | Eligibility for DPE will be established through a retrospective central review of diagnostic and pre-local control imaging. Among the patients deemed eligible for DPE, the proportion of those who undergo DPE will be determined along with 95% confidence interval. Cohen's kappa will be used to assess the concordance between site reviews and central reviews. 95% confidence of kappa statistics will be provided. |
| Secondary | Local failure rate for patients deemed eligible for DPE | Up to 5 years | Cumulative incidence curves will be used to present the local failure rates over time. |
| Secondary | Percentage of molecular biomarker testing that is resulted within the 6-week timeframe | Up to cycle 3 (each cycle is 21 days) | Assessing the feasibility of reporting diagnostic tumor molecular features in patients with clinical group III intermediate risk rhabdomyosarcoma via the molecular characterization initiative (MCI) among the first 50 Clinical Group III patients who initiated treatment and consent to MCI. If 14 or more patients cannot have diagnostic tumor molecular features identified via MCI within 6 weeks of treatment, this aim will be considered not feasible. |
| Other | Somatic molecular features TP53 mutation | Up to 5 years | Binary (1 = Mutation present, 0 = Mutation absent) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test |
| Other | Somatic molecular features MYCN amplification | Up to 5 years | Binary (1 = Amplified, 0 = Not amplified) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test. |
| Other | Somatic molecular features MYOD1 mutation | Up to 5 years | Binary (1 = Mutation present, 0 = Mutation absent) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test. |
| Other | Somatic molecular features CDK4 amplification | Up to 5 years | Binary (1 = Not amplified, 0 = Amplified) no unit. Assessed via MCI to determine association with EFS and OS. EFS and OS will be estimated using KM method. The distribution will be compared by molecular features using log-rank test. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07466316
GET https://conductscience.org/api/trials/v1/NCT07466316/registered